Kornimate/medical-research-clean huggingface dataset:
tavns for upper limb rehabilitation

Conditions: Stroke

Summary: this study explores the use of a new form of neuromodulation known as transcutaneous auricular vagus nerve stimulation (tavns) which stimulates the ear. this stimulation will be delivered concurrently with upper limb motor rehabilitation training (3 days/week for 4 weeks) in chronic stroke patients. patients will undergo a series of baseline assessments (including a brain scan), a 4-week course of motor rehabilitation, and post-assessments (including a second brain scan)

this study aims to refine and develop closed loop tavns, establish activity with key biomarkers, and show initial feasibility in a small clinical trial. for paired tavns to succeed as a clinical treatment, it is critical to develop and refine a closed-loop tavns platform that delivers stimulation concurrently during specific movements of the motor rehabilitation training. aim 1 develops this novel motion-gated closed-loop system that delivers tavns in synchrony with specific upper limb motor activation (n=5) aim 2 will combine the development of the closed-loop system with the investigator's mechanistic understanding to explore an open-label pilot trial (n=20) using closed-loop tavns paired with task-specific training to determine the feasibility, safety, and potential effect size of this novel combination therapy.

Eligibility criteria:
inclusion criteria: * 18-80 years old * ischemic or hemorrhagic stroke that occurred at least 6 months prior * completed conventional rehabilitation therapy at least one month prior * unilateral limb weakness with fugl meyer-upper extremity scale score less than or equal to 58 (out of 66) exclusion criteria: * primary intracerebral hematoma, or subarachnoid hemorrhage * bilateral upper extremity weakness * other concomitant neurological disorders affecting upper extremity motor function * documented history of dementia before or after stroke * documented history of uncontrolled depression or psychiatric disorder either before or after stroke which could affect their ability to participate in the experiment * uncontrolled hypertension despite treatment, specifically sbp (systolic blood pressure) / dbp (diastolic blood pressure) \>=180/100mmhg at baseline * contraindicated for mri scanning.

Keywords: stroke rehabilitation vagus nerve stimulation brain stimulation occupational therapy
rapid evaluation of seasonal influenza vaccine

Conditions: Influenza

Summary: this is an invitation to consider taking part in a research study occurring just before the upcoming influenza vaccination program across canada. the purpose of the study is to closely assess influenza vaccine safety and immune responses, as part of a nationwide, annual surveillance project sponsored by the public health agency of canada. such scrutiny is important given the changing nature of flu vaccines from year to year.

trivalent inactivated vaccines (tivs) are the principal tools for minimizing seasonal influenza morbidity and mortality in populations at increased risk of adverse outcomes. to keep pace with the evolution of circulating viruses the composition of tivs is annually updated. depending upon circumstances, the seasonal formulation may contain 1-3 new variant strains representing canada's supply of h1n1, h3n2 and b 2009 vaccine. standardized manufacturing processes favour consistent vaccine safety and immunogenicity profiles from year to year but unanticipated differences can and do occur. as a consequence of the unusual occurrence of "oculorespiratory syndrome" in recipients of a canadian-made tiv for 2000-2001, the canadian regulatory agency has required pre-approval clinical testing of seasonal vaccines in adults. this small scale testing (120 subjects) cannot exclude the occurrence of infrequent, troublesome adverse effects. expanded testing is desirable and would best be done soon after vaccines are approved for distribution so that results could inform the public vaccination programs that follow. having an established capacity for rapid evaluation of a new influenza vaccine will be invaluable in the event of a pandemic, when vaccines will be less thoroughly tested before being made available to protect the public. the objectives of this study are two-fold: 1. to assess the safety and immunogenicity of a seasonal tiv influenza vaccine quickly enough to inform subsequent public delivery programs. 2. to use the opportunity to refine preparedness for rapid evaluation of a pandemic influenza vaccine.

Eligibility criteria:
inclusion criteria: eligibility inclusion: * good general health * written informed consent * adults 20-64 years of age exclusion criteria: * compromised immune system * allergies to eggs or thimerosol * life-threatening reaction to previous flu vaccine * chronic illness, bleeding disorder any flu vaccine within 6 mths planning any other vaccine during study

Keywords: vaccine influenza influenza vaccine pandemic preparedness
recurrence and patient satisfaction after laparoscopic hernia repair with intraperitoneal onlay-mesh (ipom)

Conditions: Ventral Hernia; Recurrent Ventral Hernia

Summary: for laparoscopic ventral hernia repair, the technique to close the hernia gap is not well established. mainly three techniques are currently applied: * no closure at all * extracorporal suturing of the gap * intracorporal suturing of the gap all three techniques have been applied at our hospital. patients who received laparoscopic hernia repair between 2006 and 2011 will be identified from the patient database and will be contacted by phone to inquire about the outcome and the satisfaction of the surgery.


Eligibility criteria:
inclusion criteria: * hernia repair between 2006 and 2011 * laparoscopic hernia repair using intraperitoneal onlay-mesh (ipom) * patient agrees to be surveyed by phone exclusion criteria: * patient rejects participation in survey * patient already rejected use of his/her data for research purposes at admittance to surgery

Keywords: hernia, ventral
pulmonary pathophysiology and inflammatory response in patients treated with ecmo for severe respiratory failure

Conditions: Respiratory Distress Syndrome, Adult; Respiratory Distress Syndrome, Child

Summary: the purpose of this study is the observation of the course of * the mechanics of the respiratory system * the endexpiratory lung volume * and the inflammatory response in patients undergoing treatment with extracorporeal life support (ecls) due to severe refractory respiratory failure at our department.


Eligibility criteria:
inclusion criteria: * patients accepted for extracorporeal life support at our department due to the most severe forms of ards/respiratory failure not responding to conventional therapy. exclusion criteria: * malignant disease with a poor prognosis * massive intracranial bleeding
comparison of the efficacy and the safety of different schedules of administration of sub-lingual immunotherapy

Conditions: Pollen Allergy

Summary: the dose and the mode of administration of sublingual therapy remain open questions to determine the efficacy and safety of this desensitization therapy, the main purpose of this study is to evaluate if different routes of administration (oral-vestibular vs. sublingual) and a maximum dose of allergen administered are able to determine a different effect or a different incidence of side effects of the therapy in a group of patients with rhinoconjunctivitis and/or asthma due to ragweed

version 1 16/02/2011 the allergen-specific immunotherapy represents an important therapeutic option for the treatment of allergic respiratory diseases. its clinical efficacy is well demonstrated, although the mechanism of action is still under study. the main purpose of immunotherapy is to induce an allergen-specific tolerance so that the natural exposure to the allergen does not cause clinical symptoms. the clinical efficacy of standard subcutaneous immunotherapy (scit) is known. a meta-analysis cochrane on the clinical efficacy of scit in allergic rhinitis 51 double-blind studies with a total 2871 patients) demonstrated a reduction in symptoms in 73% of patients and a reduction in the use of drugs in 57%. other studies also show that scit was effective in the long term (at least 3-5 years of suspension) reduces sensitization to new allergens, prevents progression of allergic rhinitis in asthma and significantly improves the symptoms of asthma, hyper- bronchial reactivity and the use of asthma medications. sublingual immunotherapy (slit) represents an effective alternative route of administration of vaccine therapy with an allergic profile security than the scit.

Eligibility criteria:
inclusion criteria: * adults aged 18-55 years * known allergy to ragweed pollen * no immunotherapy or in progress prior to enrollment * symptoms of rhino / conjunctivitis with or without asthma exclusion criteria: * allergic to perennial allergens (moulds, mites and animal when exposed to the animal) * patients with chronic diseases (infectious, autoimmune cancer, heart or kidney) * are pregnant * chronic drug treatment with steroids and / or immunosuppressive * oral disease
study of bile acids in patients with peroxisomal disorders

Conditions: Infantile Refsum's Disease; Zellweger Syndrome; Bifunctional Enzyme Deficiency; Adrenoleukodystrophy

Summary: objectives: i. determine the effectiveness of oral bile acid therapy with cholic acid, chenodeoxycholic acid, and ursodeoxycholic acid in patients with peroxisomal disorders involving impaired primary bile acid synthesis. ii. determine whether suppression of synthesis of atypical bile acids and enrichment of bile acid pool with this regimen is effective in treating this patient population and improving quality of life.

protocol outline: patients receive oral cholic acid and oral chenodeoxycholic acid on day 1. on day 4, patients receive oral cholic and ursodeoxycholic acids. patients are assessed at 3 and 6 months for liver function response, neurologic status, and nutritional status. patients receive treatment until disease progression or unacceptable toxic effects are observed. completion date provided represents the completion date of the grant per oopd records

Eligibility criteria:
biochemically proven peroxisomal disorder, including: * zellweger syndrome * pseudo-zellweger syndrome * neonatal adrenoleukodystrophy * bifunctional enzyme deficiency * infantile refsum's disease

Keywords: zellweger syndrome adrenoleukodystrophy bifunctional enzyme deficiency inborn errors of metabolism infantile refsum's disease peroxisomal disorders pseudo-zellweger syndrome rare disease sphingolipidoses
tomosynthesis (ts) versus ultrasonography (us) in women with dense breast

Conditions: Breast Cancer

Summary: hypothesis the study aims to demonstrate at least equivalence, or non-significant difference between ts and us in women with dense breast screened negative at 2d mammography. if the equivalence between ts and us will be demonstrated, us may be substituted by ts with great benefits for the patients and for the healthcare resources. aims 1. assess if ts may detect additional cancers in dense breast that approximate us detection capability but with less false positive findings than us. 2. if ts detects new cancers in dense breast similarly to us (approximate rate or marginally lower rate), evaluate the the true positive/false positive ratio. 3. cost-analysis. in case of less false positives detected by ts, the true-positive / false positive trade-off might be strongly in favour of ts with a great potential of costs reduction.


Eligibility criteria:
inclusion criteria: * asymptomatic subjects \<50 years of age presenting for mammography, with the exception of those that, on previous mammograms are found to have breast density 1-2 according to the breast imaging reporting and data system (birads d1-2). - asymptomatic subjects ≥ 50 years of age who request mammography and have breast density birads 3-4. * no history of breast cancer - written informed consent exclusion criteria: * pregnant and breast feeding women * unable to tolerate breast compression * breast implants * unable to understand or execute written informed consent * unable or unwilling to agree to follow-up during observation period
a phase i study to examine the toxicity of allogeneic stem cell transplantation for relapsed or therapy refractory ewing sarcoma

Conditions: Ewing Sarcoma

Summary: the purpose of this study is to examine the toxicity of using allogeneic stem cell transplantation for treatment of subjects with relapsed or refractory ewing sarcoma (es). donors will consist of either human leukocyte antigen identical (hla)or 9/10 (a, b, c, dr, dq \[a, b, c, are class i markers for hla and dr and dq are class ii markers for matching for transplant for donors to match with recipient\]) matched related or unrelated donors. specifically, we will examine: * the toxicity of allogeneic stem cell transplant (sct) in this patient population, as related to incidence of grade 3-4 acute graft verse host disease (gvhd). * the incidence of transplant related mortality at 100 days.


Eligibility criteria:
inclusion criteria: * patients aged 0-30 years with relapsed or therapy refractory ewings sarcoma, excluding patients with brain metastases. patients who have received a prior autologous stem cell transplant are eligible. * related and unrelated marrow and peripheral blood stem donors must be 9/10 or 10/10 (hla a, b, c, dr, dq) matched with the recipient. exclusion criteria: * organ dysfunction: patients who have the following levels of organ system dysfunction are not eligible: * cardiac: ejection fraction less than 50 percent * renal: est. creatinine clearance less than 50 * hepatic: bilirubin greater than 3.0 * pulmonary: diffusing capacity for carbon monoxide (dlco) less than 70 percent, or for patient who cannot cooperate with pulmonary function testing, o2 saturation less than 95 percent on room air. * performance status: lansky performance less than 70; eastern cooperative oncology group (ecog) status greater than or equal to 2 * patients with an isolated recurrence of their tumor (in the site of primary tumor) greater than 1 year after completing therapy are excluded as these patients could be cured with local therapy alone. * as part of the standard of care for pre-transplant evaluation subjects will be tested for exposure to viral agents such as hepatitis b, c, htlv-1/2 and hiv. subjects testing positive for hi may be rejected as candidates for transplantation, based on the clinical judgement of the stem cell transplant physician.

Keywords: ewings sarcoma
remote ischemic preconditioning combined to local ischemic postconditioning in acute myocardial infarction

Conditions: Myocardial Infarction

Summary: rire-1 is a randomized, open-label with blinded end-point study that will test the hypothesis that remote ischemic preconditioning initiated at the time of the admission in the cathlab reduces infarct size in st-segment elevation myocardial infarction (stemi) patients treated with percutaneous coronary intervention (pci). furthermore, it will determine whether a combined approach remote ischemic preconditioning and local ischemic postconditioning can further reduce infarct size. infarct size will be determined by cardiac magnetic resonance imaging at 3-month follow-up and with 72 hours area under curve of ck-mb.

in the management of stemi, prompt reperfusion of the jeopardized myocardium is the most effective way to limit infarct size, which is a major determinant of morbidity and mortality. however, restoration of blood flow may paradoxically have deleterious consequences and lead to lethal myocardial ischemia-reperfusion injury. local ischemic postconditioning (ipost) and remote ischemic preconditioning (riper) are promising methods to decrease ischemia-reperfusion injury. the hypothesis tested in this research proposal is that riper initiated at the time of the admission in the cathlab reduces infarct size in stemi patients treated with pci. furthermore, the investigators will determine whether a combined approach riper + ipost can further reduce infarct size.

Eligibility criteria:
inclusion criteria: * age \> 18 * st-segment elevation myocardial infarction \<6h * written informed consent exclusion criteria: * previous q-wave myocardial infarction or previous coronary artery bypass graft * cardiogenic shock * cardiac arrest resuscitated before angioplasty * infarct related artery : circumflex coronary artery, right coronary artery after segment 3, left main, diagonal and marginal branches, and all coronary artery with jeopardized myocardium estimated too small. * timi 2 or 3 before angioplasty * collateral branches rentrop \>1 * timi 0 or 1 flow grade after pci * any contraindications to magnetic resonance imaging * allergy to gadolinium * patient refusal / patient not having provided written informed consent
magnetic resonance guided high intensity focused ultrasound in advanced pancreatic adenocarcinoma treatment

Conditions: Pancreatic Adenocarcinoma

Summary: the primary purpose of this protocol is to assess the exablate 2100 mr guided high intensity focused ultrasound device as an intervention for treatment of advanced stage pancreatic adenocarcinoma.

primary objective: the primary endpoints for this study will be 1) feasibility of ablation and 2) safety of ablation. secondary objective: 1.)pain reduction after ablation. 2.) evidence of inflammation at ablation site based on histology, or in blood after ablation

Eligibility criteria:
inclusion criteria: * men and women ≥ 18 years of age * patients willing to sign a written informed consent document * patients with unresectable, locally advanced or metastatic pancreatic adenocarcinoma * patients with upper abdominal pain rating at least 4 out of 10 in severity on bpi * tumor must be visualized on ct or mri, obtained within 30 days of enrollment * tumor must be accessible to the exablate mrgfus device * life expectancy ≥ 3 months, as determined by oncologist and documented in chart * ecog performance status of 0, 1, or 2 * inr \ 50,000 microl * serum urate, calcium, potassium, phosphate, creatinine \< 1.5x upper limit of normal * patients can receive general anesthesia, as determined by anesthesiologist exclusion criteria: * previous pancreatic surgery * patients with contraindication for mr imaging such as implanted metallic devices that are not mri-safe, size limitations, claustrophobia, etc. * patients with known intolerance or allergy to mr contrast agent (gadolinium chelates) including advanced kidney disease (gfr \<30 ml/min/1.73 m2) or on dialysis * pregnant and nursing patients will be excluded from the study because of a contraindication to administering mri contrast agents to these patients * patients unable to receive general anesthesia * target is: 1. not visible by non-contrast mri, or 2. not accessible to exablate device * individuals who are not able or willing to tolerate the required prolonged stationary position during treatment (can be up to 6 hrs of total table time) * patients with acute medical condition (e.g. pneumonia, sepsis) that is expected to hinder them from completing this study * patients with unstable cardiac status including: 1. unstable angina pectoris on medication 2. patients with documented myocardial infarction within six months of protocol entry 3. congestive heart failure requiring medication (other than diuretic) 4. patients on anti-arrhythmic drugs 5. patients with severe hypertension (diastolic bp \> 100 on medication) 6. patients with severe hematologic, neurologic, or other uncontrolled disease (e.g. platelets \ 1.5) * patients who are taking anti-thrombotic medication * severe cerebrovascular disease (multiple cvas or cva within 6 months)
cohort for monitoring patients with venous thromboembolic disease

Conditions: Venous Thromboembolic Disease

Summary: venous thromboembolic disease is a common pathology in the general population (1.5/1000), the prognosis of which depends in particular on the risk of recurrence. this risk depends essentially on whether the thrombotic episode was provoked or not. thus, patients who present a thromboembolic event without any contributing factor have a high risk of recurrence, which encourages clinicians to continue anticoagulant treatment for a long time. however, anticoagulant treatment is the leading cause of hospitalization for iatrogenic causes and the leading cause of iatrogenic mortality. the benefit-risk balance of treatment must be evaluated regularly, which requires a good knowledge of the risk factors for thrombotic recurrence and the risk factors for hemorrhage.

several tools have been established and validated to help clinicians assess patients' bleeding risk, notably using the has bled, haemorrage, and more recently the vte bled score. this latest score, published very recently, is the only one to have been validated in patients treated with direct oral anticoagulants. at the same time, we have recurrence risk scores such as herdoo2, which allow us to identify patients at low risk of recurrence. in order to improve the management of patients with venous thromboembolic disease, multidisciplinary thrombosis rcps have been established since 2015, bringing together hemostasis specialists, internists, oncologists, and private vascular physicians to assist clinicians in managing complex cases. • dedicated post-emergency consultations twice a week to streamline outpatient care for less serious patients this study aims to evaluate the effectiveness of these tools: score and rcp in the management of patients with venous thromboembolic disease.

Eligibility criteria:
inclusion criteria: 1. any patient over 18 years of age who has experienced at least one venous thromboembolic episode: * deep vein thrombosis confirmed by doppler ultrasound or ct venography, * pulmonary embolism confirmed by ct angiography, ventilation/perfusion scan, or confirmed dvt episode with respiratory signs consistent with pe. 2. hospitalization in the internal medicine department 3. consultation by an internal medicine physician 4. file presented at the thrombosis multidisciplinary meeting exclusion criteria: thrombosis not meeting the inclusion criteria (cerebral venous thrombosis, mesenteric)

Keywords: risk of thrombotic recurrence hemorrhagic risk factors